BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CLOSER AK

    MDR report key: 540054 · Received August 18, 2004

    Report

    Report Number
    2953144-2004-00121
    Event Type
    Injury
    Date Received
    August 18, 2004
    Date of Event
    July 16, 2004
    Report Date
    July 26, 2004
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 THE PHYSICIAN SUCCESSFULLY PERFORMED AN ARTERIOTOMY CLOSURE WITH PERCLOSE AT (CLOSER AK) DEVICE AFTER AN INTERVENTIONAL PROCEDURE. FLUOROSCOPY WAS PERFORMED BEFORE THE PROCEDURE BUT THE RESULTS ARE UNK. NO DIFFICULTIES WERE REPORTED WITH DEVICE INSERTION, DEPLOYMENT OR REMOVAL. REPORTEDLY, THE PT HAD A HISTORY OF DIABETES AND DID NOT RECEIVE INTRAVENOUS ANTIBIOTICS BEFORE OR AFTER THE PROCEDURE. IN 07/0204 THE PT WAS ADMITTED WITH COMPLAINT OF "SORENESS AND PAIN" AT THE ARTERIOTOMY SITE. THE PT WAS OBSERVED TO HAVE "ENLARGED LYMPH NODES, INFLAMMATION AND SWELLING" AT THE ARTERIOTOMY SITE. REPORTEDLY, BLOOD CULTURES WERE DRAWN; THE RESULTS WERE UNK. THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS; NAME, DOSE AND LENGTH OF ANTIBIOTIC TREATMENT IS UNK. THE PT WAS DISCHARGED FROM THE HOSP; DISCHARGE DATE IS UNK. ALTHOUGH REQUESTED, PT OUTCOME IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER AK SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R